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A comparative study of cefaclor vs amoxicillin/clavulanate in pediatric pharyngotonsillitis
Józef Haczyński1, Mieczysław Chmielik, Stanisław Bien
1Medical Department Eli Lilly Polska, Warsaw, Poland. Haczynski_jozef@lilly.com
Insights
Cefaclor (CEF) is as effective as amoxicillin/clavulanate (AMC) for treating childhood pharyngotonsillitis (PT) caused by GABHS, but CEF has fewer gastrointestinal side effects and lower relapse rates.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology and Therapeutics
Background:
- Pharyngotonsillitis (PT) caused by group A beta-hemolytic streptococci (GABHS) is a common childhood infection.
- Cefaclor (CEF) and amoxicillin/clavulanate (AMC) are frequently prescribed antibiotics for GABHS-related PT in Poland.
Purpose of the Study:
- To compare the efficacy and safety of CEF and AMC in treating GABHS-related PT in children.
- To evaluate clinical and bacteriological outcomes, including relapse and recurrence rates, and adverse events.
Main Methods:
- A multi-center, randomized, single-blinded study involving 100 children (mean age 6 years).
- Children received either CEF (20 mg/kg/d) or AMC (25 mg/kg/d) for 10 days.
- Clinical and bacteriological assessments were conducted at 14-18 days and 38-45 days post-randomization.
Main Results:
- Both CEF and AMC demonstrated high effectiveness (approximately 98%) at the post-therapy visit.
- The amoxicillin/clavulanate (AMC) group experienced significantly higher rates of relapse (21.28% vs. 15.56%) and recurrence (10.64% vs. 6.66%) compared to the cefaclor (CEF) group.
- Gastrointestinal adverse events were significantly more frequent in children treated with AMC (p<0.02).
Conclusions:
- Cefaclor (CEF) is a clinically and bacteriologically effective treatment for GABHS-related PT in children.
- CEF is comparable in efficacy to amoxicillin/clavulanate (AMC) but offers a significantly better safety profile regarding gastrointestinal side effects.
- AMC is associated with a higher risk of relapse and recurrence compared to CEF.
Background:
Pharyngotonsillitis (PT) caused by group A beta hemolytic streptococci (GABHS) is one of the most common infections of childhood. Two antibiotic suspensions, cefaclor (CEF) and amoxicillin/clavulanate (AMC), are commonly used in Poland for the treatment of PT caused by GABHS in children.
Material/Methods:
This multi-center, randomized, single-blinded study was undertaken in order to compare the efficacy and safety of CEF (20 mg/kg/d) and AMC (25 mg/kg/d) in 10 days treatment of GABHS-related PT. 100 children (mean age 6 years) were enrolled into the study. Clinical and bacteriological assessments were done on the 14-18 th, and 38-45 th days after randomization.
Results:
No GABHS strain isolated from throat smears was resistant in vitro to both antibiotics. Both antibiotics had almost 98% effectiveness at the post therapy visit. On follow-up, significantly more relapses and recurrences were observed in the AMC-treated group than in the CEF-treated group (relapse rate 21.28% vs 15.56%, p<0.02, recurrence 10.64% vs 6.66%, p<0.002). The relapse odds ratio in the AMC group was 1.7 times greater than in the CEF group, and recurrence was 1.5 times higher. There were significantly higher rates of gastrointestinal adverse events in children treated by AMC (p<0.02).
Conclusions:
CEF provides a clinically and bacteriologically effective treatment for children with PT caused by GABHS, comparable to AMC but significantly safer in terms of gastrointestinal side effects. AMC shows a greater risk of relapse and recurrence than CEF.